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Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME)

Phase 4
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer Metastatic

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Trial Information

Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME)

Advanced NSCLC remains largely fatal, with the positive impact of chemotherapy limited by
intrinsic and acquired resistance, manifested clinically by early progression and transient
responses. Current chemotherapy regimens have limited efficacy with a magnitude of survival
benefit that is still modest, and lead to significant toxicity, with many patients unable to
receive this kind of treatment, even in first line setting. There is, therefore, a great
need to provide patients with less toxic agents such as the novel targeted therapies, with
the potential to improve the efficacy and maintain a good quality of life with little
associated toxicity. TarcevaTM has shown benefit as single agent in pretreated patients who
have progressed despite platinum-based chemotherapy as summarized in section 1.2 with
minimal toxicity compared to chemotherapy, and also is currently assessed as first line
treatment in advanced NSCLC with promising preliminary efficacy results.

As previously described, TarcevaTM has recently been shown to prolong survival in a large,
randomized, placebo-controlled Phase III trial including 731 NSCLC patients no longer
candidates for further chemotherapy. This is the first and so far the only evidence of
definitive clinical benefit provided by an EGFR inhibitor in cancer patients. TarcevaTM is
the standard of care for second and third line treatment for lung cancer in USA and Europe.
However, the experience with this agent in the Middle Eastern population is very limited.
The rationale for this program is to evaluate the pattern of TarcevaTM use in patients with
advanced (inoperable stage III or IV) NSCLC who have failed standard treatment, or patients
who can not receive other systemic anticancer therapy, or patients who are not medically
suitable for chemotherapy (e.g., poor performance status). This will also enable us to study
the efficacy and safety of TarcevaTM in this population, as there may be differences in the
pharmacogenomic of this population and the previously studied population.

Inclusion Criteria:

1. Histological or cytological documented diagnosis of inoperable, locally advanced,
recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.

2. Patients must have evidence of disease but measurable disease is not mandatory.

3. 18 years of age or older.

4. ECOG performance status of 0 - 3.

5. Life expectancy of at least 12 weeks.

6. Patients who received one or two previous line of systemic chemotherapy irrespective
of EGFR mutation status.

7. No more than 2 prior chemotherapy regimens are permissible. Patients must have
recovered from any toxic effects and at least 3-4 weeks must have elapsed from the
last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids
or gemcitabine). Patients who, in the opinion of the investigator, have fully
recovered from surgery in less than 4 weeks may also be considered for the study.
Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy.

8. Patients are eligible to receive Erlotinib (TarcevaTM) as first line if they met one
of the following criteria:

1. Positive EGFR mutation tested in certified lab (although EGFR test is not
mandatory only if available).

2. Poor performance status of 3

3. Severe co morbidities and illness which make the patient not candidate for
standard systemic chemotherapy .

9. .Patient with negative EGFR mutation are still candidate for 2nd and 3rd line therapy
(although EGFR test is not mandatory only if available).

10. Prior radiotherapy is allowed.

11. Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L.

12. Serum bilirubin must be < 1.5 upper limit of normal (ULN).

13. AST and ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis).

14. Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min.

15. Able to comply with study and follow-up procedures.

16. For all females of childbearing potential a negative pregnancy test must be obtained
within 72 hours before starting therapy. Patients with reproductive potential must
use effective contraception.

17. Signed Informed Consent to participate in the study.

Exclusion Criteria:

1. Any unstable systemic disease (including active infection, grade 4 hypertension,
unstable angina, congestive heart failure, hepatic, renal or metabolic disease).

2. Prior therapy with systemic anti-tumor therapy with HER1/EGFR inhibitors (as small
molecule or monoclonal antibody therapy).

3. Any other malignancies within 5 years (except for adequately treated carcinoma in
situ of the cervix or basal or squamous cell skin cancer).

4. Patients are excluded if they have brain metastasis or spinal cord compression that
is newly diagnosed and/or has not yet been definitively treated with surgery and/or
radiation; previously diagnosed and treated CNS metastases or spinal cord compression
with evidence of stable disease (clinically stable imaging) for at least 2 months is

5. Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
keratoconjunctivitis sicca, Sjogren syndrome, severe exposure keratitis or any other
disorder likely to increase the risk of corneal epithelial lesions. The use of
contact lenses is not recommended during the study. The decision to continue to wear
contact lenses should be discussed with the patient's treating Oncologist and the

6. Patients who cannot take oral medication, who require intravenous alimentation, have
had prior surgical procedures affecting absorption, or have active peptic ulcer

7. Nursing mothers.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the pattern of use of TarcevaTM in Middle Eastern patients with advanced NSCLC

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Abdulrahman Jazieh, MD/MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Abdul Aziz Medical City for National Guard


Saudi Arabia: King Abdullah International Medical Research Center

Study ID:




Start Date:

October 2009

Completion Date:

October 2014

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary